Further study details as provided by Nathan Kline Institute for Psychiatric Research:

Estimated Enrollment:

90

Study Start Date:

December 2000

Study Completion Date:

July 2007

Detailed Description:

GAD is among the most common anxiety disorders in the elderly population. The drug lorazepam is widely utilized in the treatment of elderly individuals with GAD. However, single doses of lorazepam have been associated with cognitive toxicity that is typically evident between 1 and 2.5 hours after the drug is administered. The toxic effects include decreased memory and increased swaying, which has been associated with greater risk for falls.

Patients have 4 study visits. A psychiatric evaluation and a memory test are given at the first visit. During the second study visit, patients have a physical exam, an electrocardiogram (ECG), a neuropsychological assessment, an optional magnetic resonance imaging (MRI) brain scan, and other laboratory tests. On the third and fourth visits, patients are randomized to receive either their highest daily dose of lorazepam or placebo. Performance effects and postural sway are determined before drug administration and at 1, 2.5, and 5 hours after the drug is given. Blood samples for the determination of drug levels are also obtained.

Eligibility

Ages Eligible for Study:

60 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Lorazepam treatment for at least 3 months

Cognitively intact

Note: Individuals who are unable or unwilling to have an MRI may be included

Exclusion Criteria:

Major psychiatric disorder other than GAD

Significant medical illness which may increase the likelihood of adverse reactions to lorazepam

Severe loss of hearing or vision

Current or past history of alcohol dependence

Substance abuse within the past 6 months

MRI evidence of infection, infarction, or other lesions suggestive of intervening neurological disease

Clinical symptoms that suggest neurological disease

Dementia or other mental syndromes or disorders

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00044642